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CLEVELAND — The popular weight-loss drug Wegovy reduced the risk of serious heart problems by 20 percent in a large international study that experts say could change the way doctors treat some heart patients.
The research is the first to show that an obesity drug can not only reduce weight, but also safely prevent heart attack, stroke or cardiac death in people already suffering from obesity. heart disease, but not diabetes.
The findings could change the perception that the new class of obesity drugs are cosmetic treatments and put pressure on health insurers to cover them.
“It’s moving from a kind of therapy that reduces body weight to a therapy that reduces cardiovascular events,” said Dr. Michael Lincoff, lead author of the study and a cardiology expert at the Cleveland Clinic.
Wegovy is a high-dose version of the diabetes treatment Ozempic, which has already been shown to reduce the risk of serious heart problems in people with diabetes. The new study looked to see if the same was true in those who don’t have the condition.
Experts have known for years that losing weight can improve heart health, but no safe and effective obesity medication has been proven to reduce specific risks, said cardiology expert Dr. Francisco Lopez-Jimenez. at the Mayo Clinic. He expects the new findings to change treatment guidelines and “dominate the conversation” for years to come.
“This is the population that needs medication the most,” said Lopez-Jimenez, who had no role in the study.
In the United States, there are about 6.6 million people like those tested in the study, experts say.
The findings were published Saturday in the New England Journal of Medicine and presented at a medical conference in Philadelphia. Novo Nordisk, the maker of Wegovy and Ozempic, has asked the U.S. Food and Drug Administration to include heart benefits on Wegovy’s label, as it does on Ozempic’s.
The new study, funded by the company, included more than 17,500 people in 41 countries. Participants were aged 45 and older, had a body mass index of 27 or higher, and were followed for more than three years on average. They took typical medications for their heart problems, but they were also randomly assigned to receive weekly Wegovy injections or a dummy injection.
The study found that 569, or 6.5 percent, of those who received the drug, compared to 701, or 8 percent, of those who received the dummy vaccine had a heart attack or stroke or died of a cardiac cause. This represents an overall 20% reduction in the risk of these outcomes, the researchers reported.
This is the population that needs medication the most.
– Dr. Francisco Lopez-Jimenez
The decline appears to be driven primarily by the difference in heart attacks, but the number of serious health complications reported was too small to say whether the individual findings were caused by the drug or by chance.
Study volunteers who took Wegovy lost about 9% of their weight, while the placebo group lost less than 1%.
The Wegovy group also saw declines in key markers of heart disease, including inflammation, cholesterol, blood sugar, blood pressure and waist circumference, noted Dr. Martha Gulati, a cardiology expert at Cedars Medical Center. Sinai of Los Angeles. Changes in these markers began early in the study, before participants lost much weight.
“It means to me that how this drug works is about more than just weight loss,” said Gulati, who played no role in what she called a landmark study.
Still, “it remains unclear” to what extent the findings were a benefit of weight loss or of the drug itself, notes an editorial accompanying the study.
About a third of all study volunteers reported serious side effects. About 17% of the Wegovy group and about 8% of the control group left the study, mainly because of nausea, vomiting, diarrhea and other stomach problems.
Nearly three-quarters of participants were men and nearly 84% were white. Gulati and others said future research needs to include more women and racial and ethnic minorities.
Wegovy is part of a new class of injectable obesity medications. The U.S. Food and Drug Administration on Wednesday approved Eli Lilly’s Zepbound, a version of the diabetes drug Mounjaro, for weight control.
What this means to me is that there is more to how this medicine works than just weight loss.
– Dr. Martha Gulati
Both have high prices: monthly costs are around $1,300 for Wegovy and around $1,000 for Zepbound. And both have been in short supply for months, with manufacturers promising to increase supplies.
Medications are often not covered by private health insurance or subject to strict prior authorization requirements. Medicare, the government health plan for older Americans, is prohibited from covering medications intended solely for weight loss. But drugmakers and obesity treatment advocates have pushed for broader coverage, including asking Congress to pass a law requiring Medicare to pay for the drugs.
Results from the latest study and others that show obesity drugs have a direct effect on costly health problems could be a factor in changing the coverage calculation, said Dr. Mark McClellan, former chief the Centers for Medicare and Medicaid Services and the FDA. . In 2006, Medicare was allowed to cover weight-loss surgical procedures to treat complications of severe obesity, or even obesity itself, he noted.
This approach “could prove relevant here,” he said.